gms | German Medical Science

31st Annual Meeting of the German Retina Society

German Retina Society

22.06. - 23.06.2018, Bonn

Laser in intermediate AMD – the LEAD study – testing new ground with novel early endpoints

Meeting Abstract

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  • Robyn Guymer - University of Melbourne, Centre for Eye Research Australia, East Melbourne/AUS

Retinologische Gesellschaft. 31. Jahrestagung der Retinologischen Gesellschaft. Bonn, 22.-23.06.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. Doc18rg16

doi: 10.3205/18rg16, urn:nbn:de:0183-18rg164

Published: August 7, 2018

© 2018 Guymer.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: There is no specifically targeted intervention to slow age-related macular degeneration (AMD) progression from early stages of the disease to late vision threatening complications. The Laser intervention in Early stages of Age-related macular Degeneration (LEAD) study is a proof of concept, investigation of the safety and efficacy of sub-threshold nanosecond laser (SNL) treatment as an intervention in intermediate AMD (iAMD) to slow progression to late AMD. The LEAD study is also the first AMD trial to incorporate findings identified using several multi modal imaging (MMI) techniques, including optical coherence tomography (OCT) to define late AMD.

Methods: LEAD is a multi-centered, double-masked, randomized, sham-procedure controlled, exploratory clinical trial of sub-threshold nanosecond laser treatment (SNL). Participants with bilateral large drusen (> 125 µm), best corrected visual acuity (BCVA) ≥ 20/40 were enrolled. Participants were randomly assigned (1:1) to receive SNL or sham laser treatment to the study eye at 6-monthly visits over 36 months. The primary efficacy outcome is the number of study eyes progressing to a late AMD endpoint- either neovascular AMD (nAMD) or atrophic AMD.

Results: 292 participants were randomised to receive SNL or sham treatment. The median age of the participants at baseline was 70 years. In the study eye, the median BCVA was 84 letters read and 33.2% of the participants had pigmentary abnormalities and 24.0% had definite reticular pseuduodrusen (RPD). Atrophic endpoints were defined as traditional geographic atrophy (GA) based upon colour fundus photography, or FAF defined atrophy, or OCT defined atrophy or nascent GA. Neovascular endpoints were defined based upon fluorescein (FFA) and indocyanine green (ICG) angiography. Subretinal fluid (SRF) on OCT that was not associated with leak on FFA or polyps on ICG was determined to have non-exudative detachment of the neurosensory retina (NEDNR) and not CNV, with no endpoint recorded.

Conclusion: By using MMI to determine the presence of earlier stages of drusen associated atrophy as part of an atrophic endpoint in AMD, intervention studies commencing at earlier stages of the disease should become more feasible. Currently the OCT defined anatomical endpoints of atrophy are not recognized by regulatory authorities. MMI has also allowed detection of asymptomatic SRF in cases of iAMD, where no CNV can be identified and the handling of these cases with respect to endpoints introduces new challenges.